Rugby Cough SYRUP Guaifenesin, 4 fl oz (118 mL)

Drug Labeling and Warnings

Drug Details [pdf]

RUGBY COUGH SYRUP GUAIFENESIN- guaifenesin liquid 
Rugby Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rugby Cough SYRUP Guaifenesin, 4 fl oz (118 mL)

Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL=milliliter
• this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL-20 mL every 4 hours
children under 12 years	do not use

Other information

• each 10 mL contains:sodium 4 mg
• store at 20-25°C (68-77°F).
• alcohol-free

Inactive ingredients

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions?

1-866-467-2748

Distributed by:
Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Re-order No.370448

Rev.10/15

R-107

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

COMPARE TO ACTIVE INGREDIENT IN ROBITUSSIN® MUCUS+ CHEST CONGESTION*

NDC: 0536-1095-97

Rugby®

• FOR AGES 12 AND OVER
• NON-NARCOTIC EXPECTORANT
• ALCOHOL FREE
•   Cough
•   SYRUP
•   Guaifenesin, USP
•   4 fl oz
  (118 mL)
•   *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin®.

RUGBY COUGH SYRUP GUAIFENESIN 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1095
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1095-97	1 in 1 CARTON	04/20/2016	06/24/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/20/2016	06/24/2019

Labeler - Rugby Laboratories (079246066)

Revised: 6/2019

Document Id: 4bb0c021-ac55-40e7-af7c-5c607476261f

34390-5

Set id: 67c5ac06-facf-4780-99d2-d8a2a995ed0f

Version: 3

Effective Time: 20190627